Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06112652
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2023-10-29
Brief Title:
Neuromodulation of Different Doses to Treat TRD Guided by pBFS Technique
Sponsor:
Changping Laboratory
Organization:
Changping Laboratory
Study Overview
Official Title:
The Dosage Effect of Personalized Brain Functional SectorspBFS Guided rTMS Treatment for Treatment-resistance Depression a Randomized Double-Blind Sham-controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to explore the effectiveness and safety of different doses of neural regulation under the guidance of pBFS technology in improving symptoms in patients with moderate to severe depressive disorders
Detailed Description:
In 2022 the FDA cleared a large dosage of repetitive transcranial magnetic stimulation for treatment-resistant depression TRD which requires 10 sessions per day of 1800 pulses per session for a total of 18000 pulses per day The inter-session interval is 50 min and it costs patients 9 hours for the intervention The investigators assume that patients with moderate to severe depression may not need 10 sessions per day patients may achieve response or remission with a less amount of dosage which will save the cost of treatment Hence the investigators try to find the optimal treatment dosage for patients with moderate to severe depression
After being informed about the study and potential risks All patients giving written informed consent will undergo a screening period to determine eligibility for study entry At week 0 patients who meet the eligibility requirements will be randomized in a double-blind manner in a 11111 ratio to each active rTMS group with different pulses 41800 pulses 61800 pulses 81800 pulses 101800 pulses and sham-control group And then all participants will undergo a 5-day rTMS treatment followed by four- and eight weeks follow-up visits Participants will keep a stable treatment regime during treatment and the four-week follow-up
After being informed about the study and potential risks All patients giving written informed consent will undergo a screening period to determine eligibility for study entry At week 0 patients who meet the eligibility requirements will be randomized in a double-blind manner in a 11111 ratio to each active rTMS group with different pulses 41800 pulses 61800 pulses 81800 pulses 101800 pulses and sham-control group And then all participants will undergo a 5-day rTMS treatment followed by four- and eight weeks follow-up visits Participants will keep a stable treatment regime during treatment and the four-week follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None